EP2344878B1 - Identification des solutions de contrôle et de l'étalonnage - Google Patents

Identification des solutions de contrôle et de l'étalonnage Download PDF

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Publication number
EP2344878B1
EP2344878B1 EP09747789A EP09747789A EP2344878B1 EP 2344878 B1 EP2344878 B1 EP 2344878B1 EP 09747789 A EP09747789 A EP 09747789A EP 09747789 A EP09747789 A EP 09747789A EP 2344878 B1 EP2344878 B1 EP 2344878B1
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EP
European Patent Office
Prior art keywords
test
response
sample
control
data
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EP09747789A
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German (de)
English (en)
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EP2344878A1 (fr
Inventor
David W. Burke
Lance S. Kuhn
Terry A. Beaty
Vladimir Svetnik
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F Hoffmann La Roche AG
Roche Diagnostics GmbH
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F Hoffmann La Roche AG
Roche Diagnostics GmbH
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/101666Particle count or volume standard or control [e.g., platelet count standards, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/102499Blood gas standard or control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/103332Bilirubin or uric acid standard or control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/104165Lipid, cholesterol, or triglyceride standard or control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/104998Glucose, ketone, nitrate standard or control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/105831Protein or peptide standard or control [e.g., hemoglobin, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/106664Blood serum or blood plasma standard or control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/11Automated chemical analysis
    • Y10T436/112499Automated chemical analysis with sample on test slide
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/14Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/142222Hetero-O [e.g., ascorbic acid, etc.]
    • Y10T436/143333Saccharide [e.g., DNA, etc.]
    • Y10T436/144444Glucose

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne des solutions témoins et d'étalonnage qui sont reconnues par un dispositif de mesure et de contrôle permettant au dispositif de mesure de distinguer les données témoins et d'étalonnage des données d'essai habituelles, sur la base de l'admittance en courant alternatif des solutions témoins et d'étalonnage mesurée, qui est non caractéristique des liquides biologiques.

Claims (4)

  1. Procédé pour identifier des données témoins et/ou d'étalonnage générées par un dispositif médical, le procédé comprenant les étapes dans lesquelles :
    (a) on procure une solution témoin et/ou d'étalonnage contenant une quantité suffisante d'un modulateur choisi parmi le groupe constitué par un modulateur ionique, un modulateur organique et une de leurs combinaisons pour faire en sorte que la solution fournisse deux réponses à un signal appliqué, une réponse étant caractéristique d'un liquide biologique et une réponse n'étant pas caractéristique d'un liquide biologique ;
    (b) on applique un signal contenant des composants en courant alternatif et en courant continu sur la solution témoin et/ou d'étalonnage ;
    (c) on mesure les deux réponses ;
    (d) on utilise la réponse en courant alternatif comme réponse caractéristique pour fournir des données témoins et/ou d'étalonnage ; et
    (e) on utilise la réponse en courant continu comme réponse non caractéristique pour identifier des données témoins et/ou d'étalonnage.
  2. Procédé pour identifier des données témoins et/ou d'étalonnage générées par un dispositif médical, le procédé comprenant les étapes dans lesquelles :
    (a) on procure une solution témoin et/ou d'étalonnage contenant une quantité suffisante d'un modulateur choisi parmi le groupe constitué par un modulateur ionique, un modulateur organique et une de leurs combinaisons pour faire en sorte que la solution fournisse deux réponses à un signal appliqué, une réponse étant caractéristique d'un liquide biologique et une réponse n'étant pas caractéristique d'un liquide biologique ;
    (b) on applique un signal contenant des composants en courant alternatif et en courant continu sur la solution témoin et/ou d'étalonnage ;
    (c) on mesure les deux réponses ;
    (d) on utilise la réponse en courant continu comme réponse caractéristique pour fournir des données témoins et/ou d'étalonnage ; et
    (e) on utilise la réponse en courant alternatif comme réponse non caractéristique pour identifier des données témoins et/ou d'étalonnage.
  3. Procédé selon la revendication 1 ou 2, dans lequel l'application d'un signal implique le fait d'appliquer un signal contenant un composant en courant alternatif dont la fréquence se situe entre environ 1 Hz et environ 20 kHz.
  4. Procédé selon la revendication 1 ou 2, dans lequel le fait de procurer une solution témoin et/ou d'étalonnage implique le fait de procurer une solution contenant un modulateur ionique.
EP09747789A 2008-10-07 2009-10-02 Identification des solutions de contrôle et de l'étalonnage Active EP2344878B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/246,885 US8071384B2 (en) 1997-12-22 2008-10-07 Control and calibration solutions and methods for their use
PCT/EP2009/007079 WO2010040482A1 (fr) 2008-10-07 2009-10-02 Solutions témoins et d'étalonnage et leurs procédés d'utilisation

Publications (2)

Publication Number Publication Date
EP2344878A1 EP2344878A1 (fr) 2011-07-20
EP2344878B1 true EP2344878B1 (fr) 2012-08-01

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EP09747789A Active EP2344878B1 (fr) 2008-10-07 2009-10-02 Identification des solutions de contrôle et de l'étalonnage

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US (2) US8071384B2 (fr)
EP (1) EP2344878B1 (fr)
WO (1) WO2010040482A1 (fr)

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US8071384B2 (en) 2011-12-06
EP2344878A1 (fr) 2011-07-20
US20120031777A1 (en) 2012-02-09
US20090157344A1 (en) 2009-06-18
WO2010040482A1 (fr) 2010-04-15

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